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Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children

The SIP Study: Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05206695
Acronym
SIP
Enrollment
11760
Registered
2022-01-25
Start date
2022-05-13
Completion date
2025-10-21
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Bronchiolitis, Pneumonia

Keywords

Children, Clinical pathways, Hospital

Brief summary

This study's objective is to identify and test pragmatic and sustainable strategies for implementing a multi-condition clinical pathway intervention for children hospitalized with asthma, pneumonia, or bronchiolitis in community hospitals. The hypothesis is that the multi-condition pathway intervention will be associated with significantly greater increases in clinicians' adoption of evidence-based practices compared to control. The study is a pragmatic, cluster-randomized trial in US community hospitals. The primary outcome will be adoption of evidence-based practices over a sustained period of 2 years. Secondary outcomes include length of hospital stay, intensive care unit transfer, and hospital readmission/emergency department revisit.

Detailed description

Asthma, pneumonia, and bronchiolitis are the top causes of childhood hospitalization in the US, leading to approximately 350,000 hospitalizations and $2 billion in costs annually. Poor guideline adoption by clinicians contributes to poor health outcomes for children hospitalized with these respiratory illnesses, including longer recovery time/hospital stay, higher rates of transfer to intensive care units, and increased risk of hospital readmission. Pathways can improve clinicians' adoption of evidence-based practices/guidelines in both children's and community hospital settings. Pathways are simple, visual diagrams that guide clinicians step-by-step through the evidence-based care of a specific medical condition (accessed via paper or electronically). Most hospitals implement pathways for a single medical condition at a time (e.g., asthma). But Seattle Children's Hospital developed an intervention for simultaneously implementing pathways for multiple conditions. This intervention led to sustained guideline adoption, decreased length of stay, and decreased costs; and, these effects were comparable to those shown with single-condition pathway implementation. This multi-condition pathway intervention has not yet been studied in community hospitals, which face unique implementation barriers. The study's objective is to identify and test pragmatic and sustainable strategies for implementing a multi-condition pathway intervention for children hospitalized with asthma, pneumonia, or bronchiolitis in community hospitals. The study is a pragmatic, cluster-randomized trial in US community hospitals. The pathway intervention will be implemented using the key implementation strategies defined for this intervention (audit and feedback, electronic health record integration, plan-do-study-act cycles). The primary outcome will be adoption of evidence-based practices over a sustained period of 2 years. Secondary outcomes include length of hospital stay, intensive care unit transfer, and hospital readmission/emergency department revisit.

Interventions

BEHAVIORALMulti-condition Pathway Intervention

See Experimental/Arm 1 description

Sponsors

University of California, San Francisco
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Society of Hospital Medicine
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Participants, clinicians, and investigators cannot be masked due to the nature of the intervention. However, outcomes assessors will be masked.

Intervention model description

Participating hospitals will be randomized into either an intervention group (will test simultaneous implementation of 3 clinical pathways) or control (will continue to provide standard care)

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

Inclusion criteria

* Primary diagnosis of asthma AND age \>2 to \<18 years-old at time of admission to the hospital OR * Primary diagnosis of pneumonia AND age \>2 months and \<18 years at time of admission to the hospital OR * Primary diagnosis of bronchiolitis AND age \<2 years at time of admission to the hospital

Exclusion criteria

* Diagnosis of SARS-CoV-2 * Transfer in from another inpatient facility * Pre-existing chronic illnesses (e.g., lung disease, cardiovascular disease, neurologic disorders)

Design outcomes

Primary

MeasureTime frameDescription
Pneumonia Evidence Based Practice 1During a hospitalization, approximately 2 daysAdministration of narrow spectrum antibiotic
Pneumonia Evidence Based Practice 2During a hospitalization, approximately 2 daysNo prescription of macrolide antibiotics
Asthma Evidence Based Practice 1During a hospitalization, approximately 2 daysPrescription of inhaled corticosteroids for children greater than or equal to 5 years-old
Asthma Evidence Based Practice 2During a hospitalization, approximately 2 daysUse of metered-dose inhalers
Asthma Evidence Based Practice 3During a hospitalization, approximately 2 daysUse of an asthma pathway/bronchodilator weaning protocol
Bronchiolitis Evidence Based Practice 1During a hospitalization, approximately 2 daysNo administration of albuterol
Bronchiolitis Evidence Based Practice 2During a hospitalization, approximately 2 daysNo chest radiographs

Secondary

MeasureTime frameDescription
Length of Hospital StayDuring a hospitalization, approximately 2 daysLength Hospital Stay
Transfer to Intensive CareDuring a hospitalization, approximately 2 daysThe event of patient being transferred to an ICU
30-day Hospital Readmission or Emergency Department Revisit30 days after hospital dischargeEvent of a patient being readmitted to hospital or having an emergency department visit within 30 days of hospital discharge

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSunitha V Kaiser, MD, MSc

University of California, San Francisco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026